HSV-2 Shedding Resolution After Acyclovir Treatment

This study has been completed.

Sponsor:

University of Washington

ClinicalTrials.gov Identifier:

NCT00495573

First Posted: July 3, 2007

Last Update Posted: March 22, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of the study is to evaluate the pattern of viral shedding after beginning treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with the pattern of viral shedding during an untreated clinical recurrence of genital herpes.

HSV-2 seropositive subjects who will receive a 5-day course of acyclovir for treatment of a genital herpes recurrence.

Drug: acyclovir

400 mg acyclovir, orally three times a day for 5 days

2

HSV-2 seropositive subjects who will be observed during a genital herpes recurrence but not receive acyclovir.

Detailed Description:

The purpose of the study is to evaluate the pattern of viral shedding after beginning treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with the pattern of viral shedding during an untreated clinical recurrence of genital herpes.

Participants are asked to visit the University of Washington Virology Research Clinic for an initial screening appointment in which the clinician will ensure eligibility and informed consent will be obtained.

Participants who experience an outbreak during the next year will be asked to call the clinic at the beginning of their next outbreak. The clinician will arrange to admit the participant to the UW General Clinical Research Center (GCRC) for a 5-day hospitalization stay. During hospitalization, participants will take acyclovir (400mg 3 times daily) and genital swabs will be collected every 2 hours during the day and every 4 hours at night for 5 days. After the last swab has been taken, the study nurse at the GCRC will do a final genital exam and the participant will be discharged. Some participants will also be asked to enroll in a control arm during which the same procedures will be followed except they will not take acyclovir during the recurrence.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

HSV-2 seropositive men and women with a history of at least 3 clinical recurrences of genital herpes within the year prior to the screening visit. Participants will be recruited from the community.

Criteria

Inclusion Criteria:

Age 18 years or older

History of clinically-evident genital herpes

3 or more clinical genital herpes recurrences within the prior 12 months

HSV-2 seropositive by HSV Western Blot

Willing and able to comply with study protocol

Exclusion Criteria:

Pregnancy

Taking daily antiviral therapy for genital herpes

HIV seropositive or known immunocompromising medical condition

Plan to move from the Seattle area within the next year

Hypersensitivity to or intolerance of acyclovir

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495573